FDA 510(k)

非灭菌超声凝胶无菌超声凝胶

K号: K253255 · 2026-06-17

申请人Foshan Pingchuang Medical Technology Co., Ltd.

决定日期2026-06-17

产品代码MUI

咨询委员会RA

决定实质等同

器械摘要

Non-Sterile Ultrasound Gel Sterile Ultrasound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Pingchuang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253255. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Non-Sterile Ultrasound Gel Sterile Ultrasound Gel?

Non-Sterile Ultrasound Gel Sterile Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Foshan Pingchuang Medical Technology Co., Ltd.. The 510(k) number is K253255.

When did Non-Sterile Ultrasound Gel Sterile Ultrasound Gel receive FDA 510(k) clearance?

Non-Sterile Ultrasound Gel Sterile Ultrasound Gel received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253255.

Who is the listed applicant for Non-Sterile Ultrasound Gel Sterile Ultrasound Gel?

The FDA 510(k) record lists Foshan Pingchuang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Sterile Ultrasound Gel Sterile Ultrasound Gel?

The FDA product code for Non-Sterile Ultrasound Gel Sterile Ultrasound Gel is MUI.

列明Foshan Pingchuang Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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